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Immune Pharmaceuticals, Inc. Message Board

  • tottatn tottatn Aug 27, 2009 2:24 AM Flag

    Ceplene, "major Public health benefit"

    EMEA
    Tuesday 25 August 2009
    Location
    United Kingdom




    The European Medicines Agency gave a record number of positive opinions for new medicines in 2008. However the number of applications that were rejected by the agency, or withdrawn by the applicant, also increased significantly, according to the EMEA’s 2008 annual report.

    Both in terms of activity, and in the absolute number of positive opinions, 2008 was a ‘highly productive year,’ the agency’s executive director, Thomas Lönngren, wrote in an introduction to the report.

    In 2008, there were 66 positive opinions, up from 58 the prior year and up from 51 in 2006. The 2008 outcome compares favourably with 2002, when there were 39 positive opinions and a drop in total applications for new medicines.

    But application withdrawals and rejections also increased in 2008. A total of 30 applications had negative outcomes in the past year, up from 16 the previous year and up from 12 in 2006.

    A company usually withdraws an application if it expects to receive a negative opinion from the Committee for Medicinal Products for Human Use (CHMP). Among last year’s withdrawals were products from Wyeth Europe Ltd to treat depression and from Oncoscience AG to treat children and adolescents with relapsed brain cancer.

    Among the positive opinions were 12 products which are expected to confer major public health benefits, the agency said. These include:

    •Ceplene (histamine dihydochloride) from EpiCept GmbH for acute myeloid leukaemia;
    •Mepact (mifamurtide) from IDM SA for non-metastatic osteosarcoma;
    •Nplate (romiplostim) from Amgen Europe BV for adults with long-term immune thrombocytopenic purpura;
    •Vidaza (azacitidine) from Pharmion Ltd for adults who cannot have a bone marrow transplant and suffer from myelodysplastic syndromes;
    •Kuvan (sapropterin dihydrochloride) from Merck KGaA for hyperphenylalaninaemia, a genetic disorder which prevents some people from metabolizing a common amino acid causing it to reach toxic levels in the blood;
    •Intelence (etravirine) from Janseen-Cilag for HIV type 1 patients in whom other medicines have been ineffective;
    •RoActemra (tocilizumab) from Roche for rheumatoid arthritis;
    •Ixiaro from Intercell AG, a vaccine for Japanese encephalitis; and
    •Pradaxa (dabigatran etexilate) from Boehringer Ingelheim and Xarelto (rivaroxaban) from Bayer Health Care for the prevention of venous thromboembolism.
    Separately, the EMEA said that its budget for 2009 has been set at €188.7 million, up by 3.2% from €182.9 a year earlier. The agency’s main source of income is fees from industry for its services. The next biggest source is income from the European Union. Bugeted fees from industry represent 73.65% of total income in 2009, up from 69.07% in 2008, while income from the EU will amount to 19.29% of the total, down from 21.87% in 2008. The balance of income comes from special contributions from the EU and countries immediately outside the EU, as well as from community programmes.

    Copyright 2009 Evernow Publishing Ltd

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    • Interesting to see the reaction on Swedish threads, the short is joining the boat again. But there also seems to be an interest in the valuation of Ceplene as one of 12 major public health benefiter. A reaction that this will boost sales and make the negotiation easier for Epicept.

      Longs entering the ship? The message today from EMEA were of a more structural type. :-)

    • Major = $$$$$$$$$$$$$$$$$$$$


      Root

    • The Origin can be found in

      Annual report of the European Medicines Agency 2008
      published London, 3 July 2009
      Doc. ref.: EMEA/330566/2009
      http://www.emea.europa.eu/htms/general/direct/ar.htm

      Page 25:
      Public-health benefits of medicines recommended for authorisation in 2008
      Medicines of notable public-health interest that received a positive opinion from the CHMP in 2008
      included:
      The first medicine for use as maintenance treatment in adults with acute myeloid leukaemia, a type of
      cancer affecting the white blood cells, in combination with interleukin-2 (an anticancer medicine). It is
      used during the patients’ first ‘remission’ (a period without symptoms of the disease after the first
      course of treatment).

      • 4 Replies to stockman58a
      • TY, yes we know that, but this text tells us more i think ::))

        Among the positive opinions were 12 products which are expected to confer major public health benefits, the agency said. These include:

        •Ceplene (histamine dihydochloride) from EpiCept GmbH for acute myeloid leukaemia;
        •Mepact (mifamurtide) from IDM SA for non-metastatic osteosarcoma;
        •Nplate (romiplostim) from Amgen Europe BV for adults with long-term immune thrombocytopenic purpura;
        •Vidaza (azacitidine) from Pharmion Ltd for adults who cannot have a bone marrow transplant and suffer from myelodysplastic syndromes;
        •Kuvan (sapropterin dihydrochloride) from Merck KGaA for hyperphenylalaninaemia, a genetic disorder which prevents some people from metabolizing a common amino acid causing it to reach toxic levels in the blood;
        •Intelence (etravirine) from Janseen-Cilag for HIV type 1 patients in whom other medicines have been ineffective;
        •RoActemra (tocilizumab) from Roche for rheumatoid arthritis;
        •Ixiaro from Intercell AG, a vaccine for Japanese encephalitis; and
        •Pradaxa (dabigatran etexilate) from Boehringer Ingelheim and Xarelto (rivaroxaban) from Bayer Health Care for the prevention of venous thromboembolism

    • Great find! That's impressive!

      • 2 Replies to smithofborneo
      • The efficacy of Ceplene is the core here, not yet seen by the market. :-)

        Have a look at these graphs:

        borssnack.di.se/diseconf/forum/image.aspx?image=68A63 734-F106-49EC-AC9E-A99FC9F5DE40.gif

      • Wrote this today in Sweden:

        "En del investerare vill avvakta officiella försäljningssiffror innan de investerar i Ceplene.

        Jag tror att detta kan vara ett rationellt förhållningssätt. Det kommer säkert en rekyl på den uppgång som följer av dessa nyheter. Men på vilken kursnivå befinner vi oss då?

        Vi har IDIS som distributör av Ceplene just nu. Känner patienterna till den möjligheten?

        Söker man på "aml treatment named patient program" i Google blir den första träffen: "EpiCept Partners With IDIS For Ceplene® Named Patient ..."

        Att sedan EMEA i sin översikt över de 66 positiva utslag man fällde 2008 lyfter fram Ceplene som ett av de 12 medel som kommer ge "major public health benefits" är ju utmärkt för Ceplenes varumärke.

        Om Ceplene skulle fått ett omdöme som patienter kunde lita på, är inte denna oberoende myndighetskälla en av de bästa tänkbara?

        (1) Det kommer att öka kännedomen om Ceplene som behandlingsalternativ.

        (2) Dessutom kan den enskilde läkaren nu, än mer, med ryggen fri förskriva Ceplene.

        (3) Och - patienterna - kan känna ökad tilltro till att de genomgår en behandling där de som känner svaren på frågorna ser detta som ett gott alternativ.

        Visst kan man invänta försäljningssiffrorna för Ceplene. Jag brukar betona min önskan om att vilja minimera min risk. Givet avsaknaden av bi-effekter (förutom huvudvärk och trötthet) för Ceplene, men stor medicinsk effekt av Ceplene (den fördubblar den grupp som överlever under 60 års ålder = hälften av denna patientgruppen överlever) så ligger jag tungt i Epicept.

        Ja, faktum är att den tid vi är i just nu är lite av njutningen då jag bestämt mig för att vara med tidigt och få en kassaflödesvärdering av Epicept. Hösten kommer bli en bra period kort och gott.

        Så vad är nästa steg? Jag tror vi strax har ett partneravtal. Men sett i ljuset av att Ceplenes verkan av finansmarknaden är underskattad, så är nästa steg att Ceplene säljs via IDIS idag och imorgon - oavsett partneravtal. Kunskapen om Ceplenes verkan sprids helt enkelt. EMEAs dokument är en viktig referenspunkt för denna process. Att inte förstå EMEAs betydelse för denna kunskapsprocess, att mena att "det var väl inget nytt", gör att man kommer in sent i Epicept.

        Nästa steg tas nu, varje dag.

        Lycka till!"

 
IMNP
2.00+0.11(+5.82%)Dec 26 3:59 PMEST

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